GLP - 1FIT-COACHNCT06915090
FIT-COACH: Fitbit Intervention With Coordinated Health Coaching and PCP Support
A study testing Health Coach/Fitbit in people with GLP - 1 and Diabetes, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
In individuals with overweight/obesity, increases in physical activity (PA) can improve metabolic and cardiovascular health, independent of weight loss. However, PA levels are often low in individuals with overweight/obesity, and primary care providers (PCPs) are tasked with addressing this issue. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- GLP - 1, Diabetes, Obesity and Obesity-related Medical Conditions
- What is being tested?
- Health Coach/Fitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥27-45
- Prescribed a GLP-1/GIP within the past 6 months
- Currently taking GLP/GIP
- Age 18 years of age and older
- Patient of UMass Medical Group Primary Care Clinic
- Speaks and reads English
Who cannot join
- BMI <27 or ≥45
- Not currently taking GLP-1/GIP
- Under 18 years of age
- Prescribed GLP-1/GIP for less than 6 months
- Not a patient of UMass Medical Group Primary Care Clinic
- Does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01605
About this study
In individuals with overweight/obesity, increases in physical activity (PA) can improve metabolic and cardiovascular health, independent of weight loss. However, PA levels are often low in individuals with overweight/obesity, and primary care providers (PCPs) are tasked with addressing this issue. The investigative team developed and successfully piloted integrating a Fitbit program into clinical care, where patients were referred by PCPs, and PCPs could view PA data in the Epic electronic health record. Though feasible, PCPs wanted additional support for PA management. We also acknowledge the role of pharmacotherapy (GLP-1 agonists and GIPs) in clinical care for patients with overweighr and obesity, and the added support these patients may need. The investigative team proposes a reimbursable service of a health coach to work collaboratively with PCPs, to deliver a Fitbit-supported PA program to patients with overweight/obesity who have been prescribed a weight loss medication. In Aim 1, the team will enroll PCPs to refer patients to a 12-week health coaching program. In Aim 2, the team will conduct interviews with enrolled patients/PCPs to understand their perspectives on the program, and with new sites to establish relationships for a future R01 submission.
Read the detailed description
In Aim 1, after the patient has signed consent with the study coordinator, the coordinator will schedule the patient for their baseline in-person visit, and a flowsheet for the fitness tracker will be placed in the EHR by the study clinicians. During the baseline visit, the study team will assess height and weight, waist circumference assessment, and body composition. The 3-month follow-up visit will include the same measurements as listed above. Once baseline measures are completed, patients without a Fitbit device will be provided one for the duration of the study, which they get to keep. The same option will be available for patients who already have a Fitbit but would like one provided by the study team anyway. Patients will also install the Fitbit application and MyChart application (if needed) and sync the Fitbit with their patient portal with direction from the study team. Participants will also be instructed to wear their Fitbit for a total of 12 weeks. They will be provided a suggested step count to be accomplished from the health coach once they meet for the first session
Patients will have their first meeting scheduled with the health coach (up to 60-minutes in length, remotely). Patients will then meet with the health coach up to 5 more times (remotely) for up to 30-minutes per session over the course of the 12 weeks in the study. Health coaches will schedule meetings with the patients and communicate via Mychart. All sessions will be telehealth, conducted and recorded over Zoom. Patients will participate in the study for up to 12 weeks. Patients will receive support from the study team during the study period to troubleshoot any device related issue.
In Aim 2, patients and providers will provide verbal consent and be interviewed by the study research coordinator to assess workflow acceptability, perceptions, areas for workflow modification, preferences for initial training, preferences for frequency of review of remote monitoring data, and health coach interactions. The study team will interview patients during and at the completion of their 12 weeks to understand their perceptions on the program and supports needed, such as activity goals, feedback etc. Interviews will be 30-minutes in length, audio recorded only.
- Conditions
- GLP - 1, Diabetes, Obesity and Obesity-related Medical Conditions, Cardiovascular Diseases
- Being tested
- Health Coach/Fitbit
- Keywords
- GLP-1, Diabetes, Obesity, Health Coach, Physical Activity, Body Composition
- Medical subject headings
- Diabetes Mellitus, Obesity, Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Coach/FitbitBehavioural
Health coach visits (up to 6) will be conducted virtually and include:
Session 1:
- Assessment, wellness vision,
- Habits and goals (Stretching, strength training, cardiovascular PA/walking, Diet)
- Motivation, resources, and guidelines
- Online program orientation
- Set first week's goals
Sessions 2-5:
-Goal review, successes and challenges, new goal setting (i.e. Increase steps by 1,000/day if consistently meeting goal)
Session 6
-Review of progress, maintenance plan, final assessment
| Study group | Role | What they receive |
|---|---|---|
| GLP-1/Coaching Arm | Experimental | Patients enrolled in this arm will complete assessments at baseline and 3-months, and receive a 12-week health coaching intervention (up to 6 virtual sessions with health coach) in addition to a Fitbit wearable device. Receives: Behavioral: Health Coach/Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of enrollment
The number of enrolled patients in the study.
Measured: 6-months
Secondary outcomes (9)
Engagement with intervention
The proportion of scheduled visits the patient completes with the health coach over the 3-month study.
Measured: 3-months
Average steps per day
The average steps per day over the course of 1-week.
Measured: Baseline, 3-months
Short-Form 12 Question Health-related Quality of Life
12-item self-report survey assessing quality of life. Scores range from 0-100 with a higher score indicating more positive health-related quality of life.
Measured: Baseline, 3-months
Numeric Pain Rating Scale (NPRS)
6-questions regarding pain in body parts and doing activities of daily living using a Likert Scale from 0 to 10. Scores range from 0 (minimum) to 50 (maximum) with higher scores indicating greater levels of pain.
Measured: Baseline, 3-months
Muscle Strengthening Activities
The Muscle-Strengthening Exercise Questionnaire (MSEQ) is a 4-item questionnaire assessing the weekly frequency, session duration and intensity, types of MSE (e.g., weight machines, bodyweight exercise) and muscle groups targeted. Scores range from 0 (minimum) to 7 (maximum), with higher scores indicating higher frequency of muscle strengthening activities.
Measured: Baseline, 3-months
Short-form Dietary Recall
A short-form 15-item Food Frequency Questionnaire (FFQ) is a dietary assessment tool designed to estimate an individual's usual intake of specific food groups over a given period. The scores range from 15 (minimum) to 75 (maximum), with higher scores indicating consumption of a healthier diet.
Measured: Baseline, 3-months
Self-Report Physical Activity (IPAQ-SF)
The Physical Activity Questionnaire - Short Form (PAQ-SF) is a brief, self-reported questionnaire designed to assess an individual's physical activity levels over a specified period, typically the past 7 days. It is a condensed version of longer physical activity questionnaires, making it practical for use in research, clinical settings, and population health surveys. The minimum score is 0 (no minutes per week), and there is no maximum. Higher scores indicate higher levels of physical activity.
Measured: Baseline, 3-months
Exercise Self Efficacy
A 24-item tool assessing barriers that get in the way of physical activity on a Likert scale of 1 to 5. The scores range from 24 (minimum) to 168 (maximum) with a higher score indicating greater exercise self-efficacy.
Measured: Baseline, 3-months
Eating Self-Efficacy Brief Scale
Designed to assess an individual's confidence in their ability to control eating behaviors across different situations. It is rooted in self-efficacy theory, which emphasizes the role of belief in one's capability to perform specific behaviors. Consists of 7 items using a Likert scale of 1 to 5 for responses. The total score range is 10 (minimum) to 70 (maximum), with a higher score indicating greater eating self-efficacy.
Measured: Baseline, 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start18 Mar 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLP - 1Studies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Faro, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915090
- Sponsor's protocol ID
- STUDY00002177
- Acronym
- FIT-COACH
- Status last verified
- Dec 2025
- First submitted
- 25 Mar 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified data upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIT-COACH: Fitbit Intervention With Coordinated Health Coaching and PCP Support
- ClinicalTrials.gov ID
- NCT06915090
- Acronym / sponsor ID
- FIT-COACH / STUDY00002177
- Conditions
- GLP - 1, Diabetes, Obesity and Obesity-related Medical Conditions, Cardiovascular Diseases
- Keywords
- GLP-1, Diabetes, Obesity, Health Coach, Physical Activity, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In individuals with overweight/obesity, increases in physical activity (PA) can improve metabolic and cardiovascular health, independent of weight loss. However, PA levels are often low in individuals with overweight/obesity, and primary care providers (PCPs) are tasked with addressing this issue. The investigative team developed and successfully piloted integrating a Fitbit program into clinical care, where patients were referred by PCPs, and PCPs could view PA data in the Epic electronic health record. Though feasible, PCPs wanted additional support for PA management. We also acknowledge the role of pharmacotherapy (GLP-1 agonists and GIPs) in clinical care for patients with overweighr and obesity, and the added support these patients may need. The investigative team proposes a reimbursable service of a health coach to work collaboratively with PCPs, to deliver a Fitbit-supported PA program to patients with overweight/obesity who have been prescribed a weight loss medication. In Aim 1, the team will enroll PCPs to refer patients to a 12-week health coaching program. In Aim 2, the team will conduct interviews with enrolled patients/PCPs to understand their perspectives on the program, and with new sites to establish relationships for a future R01 submission.
Detailed description
In Aim 1, after the patient has signed consent with the study coordinator, the coordinator will schedule the patient for their baseline in-person visit, and a flowsheet for the fitness tracker will be placed in the EHR by the study clinicians. During the baseline visit, the study team will assess height and weight, waist circumference assessment, and body composition. The 3-month follow-up visit will include the same measurements as listed above. Once baseline measures are completed, patients without a Fitbit device will be provided one for the duration of the study, which they get to keep. The same option will be available for patients who already have a Fitbit but would like one provided by the study team anyway. Patients will also install the Fitbit application and MyChart application (if needed) and sync the Fitbit with their patient portal with direction from the study team. Participants will also be instructed to wear their Fitbit for a total of 12 weeks. They will be provided a suggested step count to be accomplished from the health coach once they meet for the first session
Patients will have their first meeting scheduled with the health coach (up to 60-minutes in length, remotely). Patients will then meet with the health coach up to 5 more times (remotely) for up to 30-minutes per session over the course of the 12 weeks in the study. Health coaches will schedule meetings with the patients and communicate via Mychart. All sessions will be telehealth, conducted and recorded over Zoom. Patients will participate in the study for up to 12 weeks. Patients will receive support from the study team during the study period to troubleshoot any device related issue.
In Aim 2, patients and providers will provide verbal consent and be interviewed by the study research coordinator to assess workflow acceptability, perceptions, areas for workflow modification, preferences for initial training, preferences for frequency of review of remote monitoring data, and health coach interactions. The study team will interview patients during and at the completion of their 12 weeks to understand their perceptions on the program and supports needed, such as activity goals, feedback etc. Interviews will be 30-minutes in length, audio recorded only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-1/Coaching Arm | Experimental | Behavioral: Health Coach/FitbitPatients enrolled in this arm will complete assessments at baseline and 3-months, and receive a 12-week health coaching intervention (up to 6 virtual sessions with health coach) in addition to a Fitbit wearable device. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI ≥27-45
- Prescribed a GLP-1/GIP within the past 6 months
- Currently taking GLP/GIP
- Age 18 years of age and older
- Patient of UMass Medical Group Primary Care Clinic
Key exclusion criteria (6 listed)
- BMI <27 or ≥45
- Not currently taking GLP-1/GIP
- Under 18 years of age
- Prescribed GLP-1/GIP for less than 6 months
- Not a patient of UMass Medical Group Primary Care Clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Coach/FitbitHealth coach visits (up to 6) will be conducted virtually and include: Session 1: * Assessment, wellness vision, * Habits and goals (Stretching, strength training, cardiovascular PA/walking, Diet) * Motivation, resources, and guidelines * Online program orientation * Set first week's goals Sessions 2-5: -Goal review, successes and challenges, new goal setting (i.e. Increase steps by 1,000/day if consistently meeting goal) Session 6 -Review of progress, maintenance plan, final assessment | Behavioural | GLP-1/Coaching Arm |
Primary outcome
Feasibility of enrollment
Time frame: 6-months
The number of enrolled patients in the study.
9 secondary outcomes
Engagement with intervention
Time frame: 3-months
Average steps per day
Time frame: Baseline, 3-months
Short-Form 12 Question Health-related Quality of Life
Time frame: Baseline, 3-months
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, 3-months
Muscle Strengthening Activities
Time frame: Baseline, 3-months
Short-form Dietary Recall
Time frame: Baseline, 3-months
Self-Report Physical Activity (IPAQ-SF)
Time frame: Baseline, 3-months
Exercise Self Efficacy
Time frame: Baseline, 3-months
Eating Self-Efficacy Brief Scale
Time frame: Baseline, 3-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. We will share de-identified data upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coach/Fitbit in people with GLP - 1 and Diabetes, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of enrollment (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.